Growth Hormone Deficiency Clinical Trial
Official title:
An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers
Verified date | March 2012 |
Source | Phage Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to evaluate the pharmacokinetics of Syntropin (a human growth hormone) and to determine the serum concentration of IGF-1 after Syntropin injection.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2005 |
Est. primary completion date | June 2005 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Male and female subjects between the ages of 18 and 45 years (inclusive). - Written informed consent to participate in the study. - Body mass index between 19 and 31 kg/m². - Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from 3 months prior through 7 days following the last dose of study drug: hormonal (oral, transdermal, implant, or injection), barrier (condom, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum). Subjects must have used the same method for at least 3 months prior to starting the study. - No clinically significant abnormal findings on the physical examination, medical history, electrocardiogram, or clinical laboratory results during screening. - Screening growth hormone and insulin-like growth factor I (IGF-I) within normal limits. Exclusion Criteria - A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Principle Investigator, would jeopardize the safety of the subject or impact the validity of the study results. - A history of allergic or adverse responses to growth hormone, glycerin, or metacresol, or any comparable or similar product. - Subjects who (for whatever reason) have been on an abnormal diet during the four weeks preceding the study. - Subjects who donated blood within 30 days or plasma within 14 days of the first study dosing. - Participation in a clinical trial within 30 days prior to study initiation. - Use of any over-the-counter (OTC) medication, including vitamins, within 7 days prior to or during the study. - Use of any prescription medication within 14 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential. - Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to or during the study. - Smoking or use of tobacco products within 6 months prior to or during the study. - Female subjects who are trying to conceive, are pregnant, or are lactating. - Positive serum pregnancy test at screening or urine pregnancy test prior to each drug administration for all women regardless of childbearing potential. - Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C, or a positive urine screen for alcohol or drugs of abuse. |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Novum Pharmaceutical Research Services | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Phage Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pharmacokinetics | |||
Secondary | serum concentrations of insulin-like growth factor-1 (IGF-1) |
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